Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia

March 19, 2019 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

An International Field Study for the Reliability and Validity of the Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia (EORTC QLQ-CML24)

The objective of this study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjuction with the QLQ-C30 for patients diagnosed with CML, and to investigate longitudinal relationship between satisfaction with information provision and QoL outcomes.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

337

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Innsbruck Medical University
  • Brazil
      • Paranã, Brazil
        • Complexo Hospital de Clinicas da Universidade Federal do Parana
  • China
      • Guangdong, China
        • Guangdong Medical University
  • Germany
      • Heidelberg, Germany
        • Universität Heidelberg
  • Iraq
      • Baghdad, Iraq
        • Baghdad Teaching Hospital
  • Italy
      • Ancona, Italy
        • Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
      • Bari, Italy
        • Azienda Ospedaliero-Universitaria Policlinico Consorziale
      • Bologna, Italy
        • Department of Oncology and Hematology, O.U. of Hematology, S. Orsola-Malpighi University Hospital, Bologna
      • Brescia, Italy, 21125
        • Sezione di Ematologia e Trapianti Spedali Civili
      • Cagliari, Italy
        • CTMO - Ematologia - Ospedale Binaghi
      • Catania, Italy
        • Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto
      • Genova, Italy
        • Clinica Ematologica - Dipartimento di Medicina Interna - IRCCS San Martino - IST
      • Lecce, Italy
        • Lecce ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
      • Milano, Italy
        • U.O. Ematologia 1 - Centro Trapianti di Midollo - Ospedale Maggiore Milano
      • Novara, Italy
        • Divisione di Ematologia - Dip. Di Medicina Clinica e Sperimentale & BRMA - Università Piemonte Orientale "Amedeo Avogato"
      • Palermo, Italy
        • Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone
      • Parma, Italy
        • U.O.C. di Ematologia e CTMO Az. Ospedaliero Universitaria Parma
      • Pavia, Italy, 27100
        • Div. di Ematologia IRCCS Policlinico S. Matteo
      • Piacenza, Italy
        • Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto
      • Ravenna, Italy
        • Dipartimento Oncologico - Ospedale S.Maria delle Croci
      • Reggio Emilia, Italy
        • Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
      • Roma, Italy
        • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
      • Roma, Italy
        • Divisione Ematologia - Università Campus Bio-Medico
      • Roma, Italy
        • Clinica di Ematologia - Policlinico Umberto I- Università degli Studi "Sapienza"
      • Roma, Italy
        • Divisione di Ematologia - Ospedale S.Eugenio
      • San Giovanni Rotondo, Italy
        • U.O. di Ematologia - Casa Sollievo della Sofferenza
      • Sassari, Italy
        • Ematologia - AOU Sassari
      • Verona, Italy
        • U.O di Ematologia d. U. - Azienda Ospedaliera Universitaria Integrata Verona
      • Vicenza, Italy, 36100
        • Ospedale San Bortolo
  • Malaysia
      • Kuala Lumpur, Malaysia
        • UCSI University, Faculty of Pharmaceutical Sciences
  • Netherlands
      • Eindhoven, Netherlands
        • Eindhoven and Tilburg University
  • United States
    • Georgia
      • Emory, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study sample will be composed of four different groups of patients in order to achieve the purposes of this field-testing.

Description

Inclusion Criteria:

  • Above 18 years of age.
  • Patient with confirmed diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive chronic myeloid leukemia (CML).
  • Written informed consent.
  • Patients enrolled in investigational drug-trials or other type of clinical trials are also eligible.

Exclusion Criteria:

  • Patients with a psychiatric condition or major cognitive impairment (as evaluated by their treating physician) that would hinder completion of self-reported health-related QoL questionnaires.
  • Patients who are unable to speak and read the language of the questionnaire.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective of the study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjunction with the QLQ-C30 for patients diagnosed with CML.
Time Frame: 18 months from enrollment
18 months from enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary objective is to investigate longitudinal relationship between satisfaction with information provision (outcome measure: EORTC INFO-25) and QoL outcomes (outcome measures: EORTC QLQ-C30 and QLQ-CML24).
Time Frame: 18 months from enrollment
18 months from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Study Chair: Fabio Efficace, PhD, GIMEMA Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2017

Primary Completion (Actual)

March 16, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (Actual)

March 9, 2017

Study Record Updates

Last Update Posted (Actual)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QoL-CML 0916

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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